Strategy 2 Market Provides a 1-Day Workshop On Medical Devices and Lean and Agile Methods

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After almost 20 years, many medical device companies are still confused on how to integrate lean and agile techniques in their product development process. Strategy 2 Market introduces a new 1-day workshop to address this.

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After almost 20 years, we find that many medical device companies still don’t know how to integrate lean and agile techniques in their product development process.

Strategy 2 Market finds that medical device companies are confused on whether or not they can use lean and agile techniques when developing products because of design controls. Lean and agile techniques can help these companies get their products out to market faster. This affects both the medical device company’s bottom-line and its strategic advantage in the marketplace.

FDA and ISO 13485 regulations do not prevent integration of lean and agile methods into medical devices processes. When design controls were implemented in 1997, the FDA released a guidance document that included a waterfall development process. Many medical device product developers believe the FDA expects them to use this waterfall process. The FDA doesn’t mandate any specific product development methodology.

This is what the FDA expects: Say what you are going to do, then do what you say. Therefore, you can use product development processes that integrate lean and agile techniques.

Strategy 2 Market developed a new offering: a 1-day workshop taught by Strategy 2 Market, Partner, Therese Graff, an expert in both Design Controls and product development. During this workshop (held in Chicago on June 22, 2017), she will clearly illustrate how to navigate FDA regulations and ISO requirements using lean and agile techniques for medical device companies.

Strategy 2 Market ( is a product development consulting firm specializing in helping medical device and industrial companies decrease product development complexity and increase growth.

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Mary Drotar

Kathy Morrissey
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Strategy 2 Market, Inc.

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